Improvement In Subjective Quality Research Articles

OnabotulinumtoxinA improves oral aperture in patients with scleroderma: A small clinical trial

Reduced oral aperture (ROA), resulting from systemic sclerosis (SSc), is a debilitating condition with limited treatment options. Improvement in oral function has been reported with perioral administration of botulinum toxin type A. To prospectively evaluate the efficacy of onabotulinumtoxinA (onabotA) injection in improving oral opening and quality of life in SSc patients with ROA. Seventeen women with SSc and ROA were treated with 16 units of onabotA in 8 different sites around the cutaneous lips. Measurements of maximum mouth opening were taken before treatment, at 2weeks posttreatment, and at 3months posttreatment. Function and quality of life were also assessed via surveys. Interincisor and interlabial distances were significantly increased 2weeks after treatment with onabotA (P<.001) but not 3months after. Subjective improvement in quality of life was noted. This single-institution study enrolled 17 patients and did not have a placebo control group. OnabotA appears to have a strong short-term symptomatic benefit in patients with ROA due to SSc, with possible benefit to quality of life.

0379 A Scoping Review of Validation Studies for Commercially Available CBT-i Smartphone Applications

Abstract Introduction Cognitive behavioral therapy for insomnia (CBT-I) remains the first line treatment for insomnia. CBT-I in comparison with sedative-hypnotics has similar efficacy, but with treatment durability and almost no adverse effects. Despite CBT-I being recognized as the best insomnia treatment, access remains limited. Digital CBT-I hopes to address the problem of scale, so as to deliver therapy to the masses. There are now multiple mobile applications available both on smartphone app stores, which claim to deliver evidence based CBT-i. These applications largely come at a cost and patients have to pay to access their services. The goal of this study is to review CBT-i smartphone applications to see if they are indeed validated. Methods We performed a search on the two most popular smartphone application platforms: Google Play and Apple Store. We used search terms: sleep, insomnia and CBT-I. We then searched for validation studies for those smartphone applications on Google Scholar. We included studies conducted in the past 10 years. Our second search consisted of reviewing PubMed and Google Scholar for validation studies for CBT-I applications. Our search terms consisted of CBT-I and smartphone, CBT-I and application and CBT-I and digital. Results Of the 9 validation studies that we initially found, 6 met our inclusion criteria. 3 were excluded as they did not solely use CBT-I in their applications. All 6 applications reported significant improvement in important sleep quality metrics such as sleep onset latency and total sleep time. 4 studies also reported on a subjective improvement in quality of sleep. 2 studies looked at populations with comorbidities including cannabis use disorder and epilepsy. Both studied again found improvement in sleep quality in those specific populations. There were concerning patterns of bias found amongst the reviewed studies. 3/6 investigators had direct relationships with companies which designed and marketed the applications. Conclusion dCBT-I offers an opportunity to increase accessibility to therapy. There are only a limited number of studies which have examined the effectiveness of the applications on the market. There remains serious concerns about the risk of bias and the quality of validation studies which claim to confirm the effectiveness of these applications. Support (if any)

Ultra-High-Resolution CT of the Head and Neck with Deep Learning Reconstruction-Assessment of Image Quality and Radiation Exposure and Intraindividual Comparison with Normal-Resolution CT.

To assess the benefits of ultra-high-resolution CT (UHR-CT) with deep learning-based image reconstruction engine (AiCE) regarding image quality and radiation dose and intraindividually compare it to normal-resolution CT (NR-CT). Forty consecutive patients with head and neck UHR-CT with AiCE for diagnosed head and neck malignancies and available prior NR-CT of a different scanner were retrospectively evaluated. Two readers evaluated subjective image quality using a 5-point Likert scale regarding image noise, image sharpness, artifacts, diagnostic acceptability, and assessability of various anatomic regions. For reproducibility, inter-reader agreement was analyzed. Furthermore, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and slope of the gray-value transition between different tissues were calculated. Radiation dose was evaluated by comparing CTDIvol, DLP, and mean effective dose values. UHR-CT with AiCE reconstruction led to significant improvement in subjective (image noise and diagnostic acceptability: p < 0.000; ICC ≥ 0.91) and objective image quality (SNR: p < 0.000; CNR: p < 0.025) at significantly lower radiation doses (NR-CT 2.03 ± 0.14 mSv; UHR-CT 1.45 ± 0.11 mSv; p < 0.0001) compared to NR-CT. Compared to NR-CT, UHR-CT combined with AiCE provides superior image quality at a markedly lower radiation dose. With improved soft tissue assessment and potentially improved tumor detection, UHR-CT may add further value to the role of CT in the assessment of head and neck pathologies.

Internal Fixation of Unstable Osteochondritis Dissecans of the Knee: Long-term Outcomes in Skeletally Immature and Mature Patients

Background: Osteochondritis dissecans (OCD) is a disorder originating in the subchondral bone, leading to focal lesions with risk of fragmentation and secondary damage of the articular cartilage. It remains controversial if surgical treatment of such lesions is equally successful in skeletally immature and mature patients. Purpose: To determine (1) the long-term clinical success rate after internal fixation of unstable OCD in skeletally immature and mature patients based on physeal status, (2) if patient-specific and procedural variables influence the risk of failure, and (3) patient-reported outcome measures over time. Study Design: Cohort study; Level of evidence, 3. Methods: A multicenter retrospective cohort study was conducted investigating skeletally immature and mature patients treated for unstable OCD lesions of the knee between 2000 and 2015. The healing rate was assessed by radiological imaging and clinical follow-up. Failure was defined as any definitive reoperation for the initially treated OCD lesion. Results: A total of 81 patients met inclusion criteria, including 25 skeletally immature patients and 56 patients with closed physes at the time of surgery. After a mean follow-up time of 11.3 ± 4 years, 58 (71.6%) patients had healed lesions, whereas the lesions failed to heal in 23 (28.4%) patients. No significant difference in risk of failure was observed based on physeal maturation status (hazard ratio, 0.78; 95% CI, 0.33-1.84; P = .56). Lateral versus medial condylar lesion location conferred an increased risk of failure (P < .05) for both skeletally immature and mature patients. Multivariate analysis of skeletal maturity status showed that a lateral femoral condylar location was an independent risk factor for failure (hazard ratio, 0.22; 95% CI, 0.1-0.5; P < .05). The mean patient-reported outcome scores (International Knee Documentation Committee [IKDC] score and Knee injury and Osteoarthritis Outcome Score [KOOS]) increased significantly after surgery and remained high at the final follow-up (P < .05). The final scores (mean ± SD) at a mean follow-up of 135.8 months (range, 80-249 months) were IKDC, 86.6 ± 16.7; KOOS Pain, 88.7 ± 18.1; KOOS Symptoms, 89.3 ± 12.6; KOOS Activities of Daily Living, 89.3 ± 21.6; KOOS Sport and Recreation, 79.8 ± 26.3; and KOOS Quality of Life, 76.7 ± 26.3. Conclusion: The long-term results after internal fixation of OCD fragments show high rates of healing and sustainable subjective improvement of knee function and quality of life. A healing rate of 72% was noted at a mean follow-up of 11.3 years. The stage of skeletal maturity had no significant influence on the rate of failure. Lateral femoral condylar lesion location is an independent risk factor for failure in skeletally mature and immature patients.

Genetic Behavioral Trait Assessment Paired With Personalized Recommendations and Coaching to Support Mental Health and Wellness

AbstractBackgroundGenetics, environment, and lifestyle each contribute to human behaviors. We have developed a direct-to-consumer genetic assay (Mental Health Map) that allows users to explore their genetic behavioral predispositions and potential interventions that may positively influence mental health and wellness. Based on preliminary consumer feedback suggesting increased desire to take action on their mental health and wellness, we initiated a pilot study to assess several measures of mental health and self-care in individuals both before and after reviewing their Mental Health Map.MethodsThis was a virtual case series in adults who purchased a Mental Health Map. Subjects served as their own control based on survey responses leading up to genetic testing and up to 7 weeks after an introductory coaching session. Coaching included a demonstration of how to navigate the interactive online report, discussion of key results, and provision of additional external resources as appropriate. The co-primary measures were changes in quality of life as measured by WHO-5, report of initiating a discussion or seeking mental health care with a health care provider, report of initiating and sustaining positive lifestyle changes, and subjective improvements in stress management, sleep quality, mood, focus, and social interactions. Secondary measures were changes in GAD-7 and PHQ-9.ResultsTwenty-seven individuals completed the study. Average WHO-5 at baseline was 41.2 which numerically increased to 48.3 at week 7, suggesting improved quality of life, but this effect was not statistically significant. 42.3% of individuals were in treatment with a mental health provider at the time of survey. Of those not in treatment, 33.3% were actively seeking professional mental healthcare prompted by the coaching session. At week 6, 87% of survey respondents (n=15) asserted that they continued to make lifestyle changes that improved stress; 74% made changes to improve mood and 80% made changes that improved their habits. Percentage of respondents who reported lifestyle changes to improve sleep, focus, and social interactions were all less than 70%. In secondary outcomes, average GAD-7 at baseline was 8.9 and decreased to 6.7 at week 7, while PHQ-9 averaged 10.3 at baseline and decreased to 7.5 at week 7. Neither of the secondary outcome measures achieved a statistically significant difference.ConclusionDespite the small patient population, this pilot study provides proof-of-concept that Mental Health Map and the accompanying coaching session encourages participants to make positive lifestyle changes and prompts pursuit of a healthcare professional. We also saw numerical trends toward modest improvements in quality of life, anxiety, and depression symptoms, although these differences were not statistically significant, and may require larger sample sizes.FundingGenomind

Orofacial myofunctional reeducation assisted by a prefabricated reeducation appliance: a systematic review of the literature

Several cross-sectional studies have shown the association of a dysfunctional orofacial environment with a greater prevalence of malocclusions. Orofacial myofunctional reeducation (OFMR) is the rehabilitation of the muscles, functions and resting postures of the orofacial complex. It is used in the therapeutic management of orofacial dysfunction in patients of all ages and with a wide range of disorders and comorbidities. RMOF mainly uses isotonic and isometric exercises targeting the oral and oropharyngeal structures, combined with specific exercises for ventilation, swallowing and mastication. It may involve the use of prefabricated reeducation appliances (PRAs), which may also be prescribed to modify the shape and relationship of the dental arches. The primary objective of this systematic review of the literature was to describe and evaluate the efficacy of prefabricated reeducation appliance-assisted OFMR in orthodontics, occlusodontics and dental sleep medicine. Its secondary objective was to assess whether the use of currently available PRAs is associated with adverse effects. The systematic literature review was undertaken using five electronic databases: Medline (via PubMed), Web of Science, Cochrane Library, Embase, and Google Scholar, to identify studies evaluating the efficacy of PRA-assisted OFMR in the treatment of orofacial dysfunctions and parafunctions, temporo-mandibular dysfunction (TMD) or obstructive sleep apnea (OSA) in children, adolescents and adults, published until 20 March 2023. The primary outcome of interest was the therapeutic efficacy of PRA-assisted OFMR. In patients with obstructive sleep apnoea (OSA), efficacy was assessed primarily by a decrease in the apnoea/hypopnoea index (AHI) of at least five episodes per hour from baseline, improvement in subjective sleep quality, sleep quality measured by nocturnal polysomnography and subjectively measured quality of life. In patients with orofacial dysfunctions, parafunctions or TMD, efficacy was assessed mainly by electromyography (EMG), history and clinical examination. Secondary outcomes were dentoalveolar or skeletal improvements, and possible adverse effects of the PRAs used, including adverse effects on occlusion. Only fourteen studies met all inclusion criteria: two randomised controlled trials, one non-randomised controlled trial, five prospective case-control studies, two retrospective case-control studies, two prospective case series and two retrospective case series. The two randomised controlled trials were assessed as "low risk of bias" according to the Cochrane Back Review Group's 12 risk of bias criteria. The methodological quality of the remaining 12 included studies was assessed using the ROBINS-I tool, according to the recommendations of the Cochrane Handbook. One was judged to have a measured risk of bias, eight a significant risk of bias and three a critical risk of bias. Based on the available evidence, PRA-assisted OFMR results in a statistically significant (p=0.0425) reduction in AHI in children with mild to moderate obstructive sleep apnea. In children with obstructive sleep apnoea undergoing adenoid and/or tonsil surgery, postoperative OFMR combined with a flexible PRA leads to a greater reduction in AHI compared to a control group and an improvement in SaO2 at 6 months and 12 months after surgery (p<0.01). It also contributes to greater improvement in sleep disturbance, physical fitness, daytime lethargy in the treated group than in the control group 6 months and 12 months after surgery (p<0.05). PRA-assisted OFMR provides correction of atypical swallowing and improvement in orofacial muscle balance. GRPs are generally less effective than activators for the treatment of Class II Division 1 malocclusions and appear to cause more adverse effects, mainly vestibuloversion of the mandibular incisors. The use of PRA-assisted OFMR for the management of TMD is not validated by current evidence. Published data, albeit of uneven methodological quality, appear to show the superiority of OFMR combined with the use of a PRA, compared with the implementation of OFMR without PRA. Prospective studies with large sample sizes would be useful to better evaluate the new therapeutic possibilities brought by the combination of OFMR with a PRA. Continued attention should be paid to the monitoring of possible adverse effects of PRA-assisted OFMR on the dental arches, especially the vestibuloversion of the mandibular incisors. It might be useful to reflect on the relevance of the arguments put forward by manufacturers about the particularities of their devices and their supposed effects. PRA-assisted OFMR appears to be a necessary paradigm shift, which it seems useful to bring to our patients. This protocol was registered on March 02, 2023 in the International Prospective Register of Systematic Review (PROSPERO) and received the CRD number: CRD42023400421.

Effect of massage therapy on sleep quality in critically ill patients: A systematic review and meta-analysis.

The aim of the study was to compare the effects of massage interventions on sleep quality among patients in the adult critical care unit. Massage interventions have positive effects when applied to manage sleep quality in critical care units. However, research identifying the effect of massage intervention is limited. This study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Five databases were searched from their inception to 15 April 2022 (the last search was conducted on 15 November 2022, but it yielded no additional eligible studies). The literature search was conducted using Embase, MEDLINE, the Cochrane Library, CINAHL, PsycINFO and additional sources such as Google Scholar. The Cochrane risk of bias tool for randomised trials (RoB 2.0) was used to assess the risk of bias. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) system assessed the certainty of evidence and recommendations. In total, ten randomised controlled trials comprising 569 participants were used in the systematic review, and eight trials were included in the meta-analysis. Subgroup analysis revealed significant effects of foot reflexology massage on subjective sleep quality. Massage therapy for a two-night duration in cardiac care unit patients exhibited a significant effect on subjective sleep quality. The overall GRADE certainty of evidence was low. Massage intervention, particularly foot reflexology massage, with a two-night duration showed improvement in subjective sleep quality among critically ill patients. Although evidence quality was low, the results suggest that massage interventions provide a non-invasive, low-cost and effective way to promote sleep quality in critically ill adult patients. Massage interventions can enable nurses to recommend and implement strategies promoting and improving sleep quality among critically ill patients. The review protocol was registered a priori and published online in the PROSPERO database of systematic reviews (www.crd.York.ac.uk/Prospero with the registration number # CRD42022332371). No patient or public contribution if such details are not necessary or do not apply to your work and state why.

The Virtual Sleep Lab—A Novel Method for Accurate Four-Class Sleep Staging Using Heart-Rate Variability from Low-Cost Wearables

Sleep staging based on polysomnography (PSG) performed by human experts is the de facto "gold standard" for the objective measurement of sleep. PSG and manual sleep staging is, however, personnel-intensive and time-consuming and it is thus impractical to monitor a person's sleep architecture over extended periods. Here, we present a novel, low-cost, automatized, deep learning alternative to PSG sleep staging that provides a reliable epoch-by-epoch four-class sleep staging approach (Wake, Light [N1 + N2], Deep, REM) based solely on inter-beat-interval (IBI) data. Having trained a multi-resolution convolutional neural network (MCNN) on the IBIs of 8898 full-night manually sleep-staged recordings, we tested the MCNN on sleep classification using the IBIs of two low-cost (<EUR 100) consumer wearables: an optical heart rate sensor (VS) and a breast belt (H10), both produced by POLAR®. The overall classification accuracy reached levels comparable to expert inter-rater reliability for both devices (VS: 81%, κ = 0.69; H10: 80.3%, κ = 0.69). In addition, we used the H10 and recorded daily ECG data from 49 participants with sleep complaints over the course of a digital CBT-I-based sleep training program implemented in the App NUKKUAA™. As proof of principle, we classified the IBIs extracted from H10 using the MCNN over the course of the training program and captured sleep-related changes. At the end of the program, participants reported significant improvements in subjective sleep quality and sleep onset latency. Similarly, objective sleep onset latency showed a trend toward improvement. Weekly sleep onset latency, wake time during sleep, and total sleep time also correlated significantly with the subjective reports. The combination of state-of-the-art machine learning with suitable wearables allows continuous and accurate monitoring of sleep in naturalistic settings with profound implications for answering basic and clinical research questions.

The role of flumazenil in generalised anxiety disorder: a pilot naturalistic open-label study with a focus on treatment resistance

Anxiety disorders are highly prevalent and chronic disorders with treatment resistance to current pharmacotherapies occurring in approximately one in three patients. It has been postulated that flumazenil (FMZ) is efficacious in the management of anxiety disorders via the removal of α4β2δ gamma-aminobutyric acid A receptors. To assess the safety and feasibility of continuous low-dose FMZ infusions for the management of generalised anxiety disorder (GAD) and collect preliminary efficacy data. Uncontrolled, open-label pilot study. Participants had a primary diagnosis of generalised anxiety disorder (GAD) and received two consecutive subcutaneous continuous low-dose FMZ infusions. Each infusion contained 16 mg of FMZ and was delivered over 96 ± 19.2 h. The total dose of FMZ delivered was 32 mg over approximately 8 days. Sodium valproate was given to participants at risk of seizure. The primary outcome was the change in stress and anxiety subscale scores on the Depression Anxiety Stress Scale-21 between baseline, day 8, and day 28. Nine participants with a primary diagnosis of GAD were treated with subcutaneous continuous low-dose FMZ infusions; seven participants met the criteria for treatment resistance. There was a significant decrease in anxiety and stress between baseline and day 8 and baseline and day 28. There was also a significant improvement in subjective sleep quality from baseline to day 28 measured by the Jenkins Sleep Scale. No serious adverse events occurred. This study presents preliminary results for subcutaneous continuous low-dose FMZ's effectiveness and safety in GAD. The findings suggest that it is a safe, well-tolerated, and feasible treatment option in this group of patients. Future randomised control trials are needed in this field to determine the efficacy of this treatment.

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis.

Sleep disturbances are common and bothersome among cancer and noncancer populations. Suanzaoren (Ziziphi Spinosae Semen) is commonly used to improve sleep, yet its efficacy and safety are unclear. We systematically searched PubMed, Cochrane Library, and EMBASE from inception through October 5, 2021, to identify randomized trials of Suanzaoren. We included randomized trials comparing Suanzaoren to placebo, medications, cognitive behavioral therapy (CBT), or usual care for improving sleep outcomes in cancer and noncancer patients with insomnia or sleep disturbance. We performed a risk of bias analysis following Cochrane guidelines. Depending on heterogeneity, we pooled studies with similar comparators using fixed- and random-effects models. We included participants with insomnia disorder (N = 785) or sleep disturbance (N = 120) from 9 trials. Compared with placebo, Suanzaoren led to significant subjective sleep quality improvements in participants with insomnia and patients with sleep disturbance combined (standard mean difference -0.58, 95% CI -1.04, -0.11; P < .01); Compared with benzodiazepines or CBT, Suanzaoren was associated with a significant decrease in insomnia severity (mean difference -2.68 points, 95% CI -5.50, -0.22; P = .03) at 4 weeks in the general population and cancer patients. The long-term effects of Suanzaoren were mixed among trials. Suanzaoren did not increase the incidence of major adverse events. The placebo-controlled studies had a low risk of bias. Suanzaoren is associated with short-term patient-reported sleep quality improvements among individuals with insomnia or sleep disturbance. Due to the small sample size and variable study quality, the clinical benefits and harms of Suanzaoren, particularly in the long term, should be further assessed in a sufficiently powered randomized trial. PROSPERO CRD42021281943.

Image Generation Method Using Weight Maps for Subjective Quality Improvement in Two-Dimensional Image Synthetic Integral Three-Dimensional Display

Image Generation Method Using Weight Maps for Subjective Quality Improvement in Two-Dimensional Image Synthetic Integral Three-Dimensional Display

Subjective Improvement of Sleep in Insomnia Patients Treated at a Day Rehabilitation Centre After the Use of EEG Neurofeedback Therapy – a Pilot Study

Introduction: Insomnia affects nearly 1/3 of the worldwide population. Electroencephalography neurofeedback (EEG-NFB) is one of the methods used in applied psychophysiology, which can improve nightly sleep scheme. Research objective: The aim of this pilot study was to assess the relative effect of a 20-day neurorehabilitation intervention based on EEG-NFB therapy in insomnia patients treated at a day rehabilitation centre. Materials and methods: Seventy-four patients with insomnia: 28 women (mean age ± SD: 67.9 ± 8.84 years, range: 42–83 years) and 46 men (mean age ± SD: 63.0 ± 9.24 years, range: 42-80 years) were subjected to the EEG-NFB training-neurorehabilitation using the C4 protocol: sensorimotor rhythm (SMR) (12-15 Hz)/theta (4-7 Hz). The individual everyday EEG-NFB training consisted of 20, 30-minute sessions. Before and after the training, the data was collected from 12-electrode quantitative EEG (QEEG) tests. In addition, several standardised psychological questionnaires were performed: Pittsburgh Sleep Quality Index (PSQI), State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI). Results: The EEG-NFB therapy reduced anxiety (7.39 ± 1.0 vs. 6.12 ± 0.88 in STAI, p&lt; 0.001) and improved patients' mood (17.6 ± 3.9 vs. 14.65 ± 3.39 in BDI, p&lt; 0.001). During the PSQI test, the time of falling asleep and number of night awakenings were statistically reduced (both p&lt;0.001). However, there was no significant difference in the -SMR amplitude between pre- to post-treatment (9.15 ± 3.11 and 8.62 ± 2.82, respectively, p=0.095). Conclusions: Due to the subjective improvement of sleep quality, without statistically significant changes in the electrophysiological record (expressed by SMR amplitude), it is advisable to continue research with the use of EEG-NFB therapy.

Exercise Training Program Improves Subjective Sleep Quality and Physical Fitness in Severely Obese Bad Sleepers.

Sleep quality is an important modulator of neuroendocrine function, as sleep problems are related to metabolic and endocrine alterations. The main objective was to determine the effects of an exercise training program on the sleep quality of severely obese patients with sleep problems. The secondary objective was to determine the relationship between fitness and anthropometric parameters with sleep quality scores. Thirty severely obese patients participated in 16 weeks of PA intervention (age: 39.30 ± 11.62 y, BMI: 42.75 ± 5.27 kg/m2). Subjective sleep quality, anthropometric parameters, and fitness (i.e., handgrip strength and cardiorespiratory fitness) were measured. Two groups were defined as good sleepers (n = 15, 38.06 ± 12.26, men = 1) and bad sleepers (n = 15, 40.53 ± 11.23, men = 3). The good sleeper group reported improvement in cardiorespiratory fitness (61.33 ± 68.75 m vs. 635.33 ± 98.91 m, p = 0.003) and handgrip strength (29.63 ± 9.29 kg vs. 31.86 ± 7.17 kg, p = 0.049). The bad sleeper group improved their cardiorespiratory fitness (472.66 ± 99.7 m vs. 611.33 ± 148.75 m, p = 0.001). In terms of sleep quality dimensions, the bad sleeper group improved their subjective sleep quality (p < 0.001), sleep latency (p = 0.045), sleep duration (p = 0.031), and habitual sleep efficiency (p = 0.015). Comparing the changes in both groups (∆), there were differences in subjective sleep quality scores (∆ = 2.23 vs. ∆ = -3.90, p = 0.002), where 86.6% of the bad sleeper group improved sleep quality (p = 0.030). An increase in handgrip strength was correlated to improving sleep quality scores (r = -0.49, p = 0.050). Severely obese bad sleepers improved their subjective sleep quality, the components of sleep, and cardiorespiratory fitness through an exercise training program. Improvement in subjective sleep quality was linked to an increase in handgrip strength.

Outcomes of Lymphovenous Anastomosis for Lower Extremity Lymphedema: A Systematic Review.

Background:Lymphovenous anastomosis (LVA) is a microsurgical treatment for lymphedema of the lower extremity (LEL). This study systematically reviews the most recent data on outcomes of various LVA techniques for LEL in diverse patients.Methods:A comprehensive literature search was conducted in the Ovid MEDLINE, Ovid EMBASE, and Scopus databases to extract articles published through June 2021. Studies reporting data on objective postoperative improvement in lymphedema and/or subjective improvement in quality of life for patients with LEL were included. Extracted data comprised demographics, number of patients and lower limbs, duration of symptoms before LVA, surgical technique, duration of follow-up, and objective and subjective outcomes.Results:A total of 303 articles were identified and evaluated, of which 74 were ultimately deemed eligible for inclusion in this study, representing 6260 patients and 2554 lower limbs. The average patient age ranged from 22.6 to 76.14 years. The duration of lymphedema before LVA ranged from 12 months to 11.4 years. Objective rates of improvement in lymphedema ranged from 23.3% to 100%, with the greatest degree of improvement seen in patients with early-stage LEL.Conclusions:LVA is a safe and effective technique for the treatment of LEL of all stages. Several emerging techniques and variations may lead to improved patient outcomes.

A Cross-Sectional Study of the Impact of the COVID-19 Pandemic on Previously Diagnosed Patients With Fibromyalgia.

IntroductionCoronavirus disease 2019 (COVID-19) was a one-of-its-kind pandemic due to its high infectivity and mortality rate. Prolonged lockdown periods imposed during the pandemic saved many lives but, on the other hand, had a huge psychological and clinical impact on patients suffering from chronic medical illnesses.AimsThis study aimed to find the impact of the COVID-19 pandemic on patients with previously diagnosed fibromyalgia.MethodsA prospective observational study including the cohort of previously diagnosed cases of fibromyalgia as per American College of Rheumatology (ACR) 2010 criteria where the patients were evaluated by an online survey for socio-demographic profile, subjective improvement, and objective improvement in quality of life by the Fibromyalgia Impact Questionnaire-Revised (FIQR). Pre and post-COVID-19 scores were analyzed. The statistical procedure used included the chi-square test.ResultsA total of 78 subjects were recruited for the study, with a female preponderance (75%) and mean (SD) age of 37.2 (9.2) years. The duration of symptoms was nine to 12 months followed by more than 12 months at the time of the first consultation for the majority of subjects. Sixty-five percent (65%) of subjects had no improvement or deterioration on FIQR.Statistical analysisThis included mean, standard deviation, proportions, percentages, and the chi-square test.ConclusionCOVID-19 had a significant negative impact on patients with fibromyalgia even on continued pharmacological treatment. However, there was no statistically significant data on the comparison of the overall mean score of FIQR and each domain individually with the continuation of treatment and improvement of symptoms.

Effectiveness of a specific physical therapy program for Charcot-Marie-Tooth on sleep quality, pain perception, and nocturnal cramps: a pilot study.

IntroductionChronic pain, nocturnal cramps, and sleep alterations are prevalent symptoms and signals in Charcot-Marie-Tooth disease patients. Sleep and pain are bidirectionally related and physical therapy can improve the binomial sleep and pain/nocturnal cramps. Therefore, we hypothesized that the application of a specific physical therapy program for Charcot-Marie-Tooth disease would improve sleep quality, pain perception, and nocturnal cramps.Material and MethodsA non-randomized controlled study that included 9 Charcot-Marie-Tooth disease patients (intervention group - physical therapy program) and 8 controls (active control group - booklet on sleep hygiene). The intervention lasted 8 weeks, three sessions per week. The effects were evaluated ten days before (baseline) and ten days after the intervention (post). Our primary outcome was sleep quality (subjective and objective, assessed by Pittsburgh sleep quality index and actigraphy, respectively); and secondary outcomes were pain perception (brief pain inventory) and nocturnal cramps (self-report).ResultsThe program was able to improve the subjective sleep quality (p=0.005) and nocturnal cramps (p<0.001) but had no effect on actigraphy data (p>0.05) neither on pain perception (p>0.05).ConclusionOur initial hypothesis was partially corroborated: the improvement in subjective quality of sleep and nocturnal cramps is already beneficial for the health promotion of the volunteers in this study affected by the disease. Our findings may serve as a basis for future research to develop a program focused on the treatment of analgesia, which can improve pain perception and alter the objective quality of sleep.

Dark nighttime interventions and sleep quality in intensive care unit patients: A systematic review and meta‐analysis

AbstractBackgroundSleep disturbances resulting from adverse clinical and environmental conditions are associated with unfavourable outcomes in critically ill patients.AimTo collect evidence on the effect of dark nighttime interventions on sleep quality and daytime sleepiness in intensive care unit (ICU) patients.Study DesignThe study followed the Preferred Reporting Items for Systematic reviews and Meta‐Analyses recommendations. This is a systematic review and meta‐analysis of experimental and quasi‐experimental studies, developed with adult patients admitted to ICUs and submitted to measures such as environmental brightness reduction, eye mask or blue light‐blocking glass use at night. Outcomes were subjective or objective sleep quality and excessive daytime sleepiness. Search was carried out in the PubMed/MEDLINE, Cochrane Library, Embase, Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science, and Scopus databases, using grey literature. Covidence software, Cochrane tools and Grading of Recommendations Assessment, Development and Evaluation were used, and a meta‐analysis was performed using RevMan software.ResultsThirteen articles were included in the systematic review and seven studies were included in the meta‐analysis. There were 3 trials with 175 participants regarding lighting reduction and environmental noise control versus the usual routine, 2 of these trials, with 96 patients, were compiled in meta‐analysis in which it was observed a significant statistical improvement in subjective sleep quality, mean difference (MD) of 11.89 points (0–100); 95% confidence interval (CI) 8.0–15.76, evidence set with moderate certainty, as well as this same intervention, reduced daytime sleepiness in 2 trials, 135 participants (standardized MD −0.63; 95% CI −0.98 to −0.28), with low certainty evidence. Eye masks versus usual routine, 2 trials, 126 participants, improved subjective sleep quality (MD of 10 points; 95% CI 7.97–12.03), with moderate certainty of evidence. Eye mask use combined with other therapies versus usual routine, 5 trials, 204 participants, improved subjective sleep quality in all studies, with low certainty of evidence. Objective sleep assessment was not improved with these interventions.ConclusionsThis review shows some benefits of nighttime interventions on subjective sleep quality and excessive sleepiness, however, there is an urgent need to conduct better and more robust studies in this field.Relevance to Clinical Practiceapplying measures such as lighting reduction and eye mask use significantly improves sleep quality.

Safety of Platelet-Rich Plasma Subepithelial Infusion for Vocal Fold Scar, Sulcus, and Atrophy.

To demonstrate the safety profile of platelet-rich plasma (PRP) as an injectable therapeutic for the treatment of vocal fold scarring and atrophy. Preliminary report on a prospective clinical trial of patients with vocal fold scar or atrophy undergoing unilateral vocal fold subepithelial infusion with autologous PRP. Enrolled patients underwent four subepithelial injections spaced 1 month apart. Adverse events were assessed peri and post-injection at each session. Patient-reported outcomes were collected at every visit using the Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI) questionnaires. Twelve patients underwent unilateral vocal fold injection with autologous PRP prepared according to Eclipse PRP® system protocol. Forty-three injections were performed using a peroral or percutaneous approach. An average of 1.57 ± 0.4 cc (range 0.6-2.0 cc) injectate was used. All patients tolerated the procedure without difficulty or peri-procedural complications. The average duration of follow-up was 3.6 ± 1.8 months. No significant inflammatory reactions or adverse events were seen to date. There was statistically significant improvement in patient-reported outcomes at the 3 month follow up (n=9) follow-up (mean ΔVHI-10=10.8, p < 0.001, mean ΔVFI=18.9, p=0.01, t test, paired two sample for means, two-tail). All nine patients who completed the series of four injections subjectively (yes/no) reported they were satisfied with the results. This prospective study cohort demonstrated a favorable safety profile, with no adverse events or peri-procedural complications. Subjective improvements in vocal quality and reduction in vocal fatigue need to be clinically correlated with further study. 4 Laryngoscope, 133:647-653, 2023.

Quality of Voice in Patients With Partial Deafness Before and After Cochlear Implantation

Quality of Voice in Patients With Partial Deafness Before and After Cochlear Implantation

Erenumab Impact on Sleep Assessed With Questionnaires and Home-Polysomnography in Patients With Migraine: The ERESON Study.

IntroductionMigraine and sleep share a complex and unclear relationship. Poor sleep may trigger migraine attacks; migraine, in turn, is frequently associated with sleep disorders. Few previous studies used questionnaires to assess sleep changes in patients who were treated with migraine-preventive medications (MPMs). More extensive polysomnography (PSG)-based studies for this purpose were not available.ObjectiveTo investigate possible sleep changes in patients with migraine treated with erenumab, using validated sleep questionnaires and home-PSG.MethodsThis observational, prospective, open-label pilot study was conducted at the Clinical Neurology Unit Headache Center of Udine University Hospital from 2020 to 2021. Patients were treated with erenumab as monotherapy or add-on treatment for migraine prevention. Sleep changes were evaluated with questionnaires and polysomnographic recordings at baseline, after 3 and 12 months of treatment. Erenumab efficacy and safety in migraine prophylaxis were also investigated.ResultsTwenty-nine patients completed 3 months of follow-up, whereas 15 patients completed 12 months. We found a weak trend of improvement in daytime somnolence after 3 months of treatment, with stronger results after 12 months (median Epworth Sleepiness Scale (ESS) score from 6.0 to 4.0, p = 0.015); a significant improvement in subjective sleep quality (median Pittsburgh Sleep Quality Index (PSQI) total score from 7 to 5; p = 0.001) was also observed. Home-PSG showed a significant increase in objective sleep efficiency (SE), both after 3 (from 88.1 to 91.0, p = 0.006) and 12 months (from 87.1 to 91.0, p = 0.006) of treatment. In addition, our data confirmed erenumab effectiveness and safety in migraine prevention.ConclusionOur study demonstrated an improvement in both subjective and objective sleep quality in patients treated with a migraine-preventive therapy. Erenumab, in particular, does not cross the blood-brain barrier (BBB), thus a direct effect on sleep is unlikely. Future studies are needed to better understand the mutual influence between migraine and sleep disorders.